| CTRI Number |
CTRI/2024/02/062607 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of outcomes between removal of gall bladder from umbilicus and upper abdomen in laparoscopic gall bladder surgery |
|
Scientific Title of Study
|
A comparative study of outcomes between umbilical and epigastric port retrieval of gall bladder in elective laparoscopic cholecystectomy for gall stone disease: A double blinded randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ammapalem Satish |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh. |
| Address |
Department of General Surgery, Level 6, Medical college building, All India Institute of Medical Sciences, Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9000932213 |
| Fax |
|
| Email |
satishsvmc2k8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh. |
| Address |
Department of General Surgery, Level 6, Medical college building, All India Institute of Medical Sciences, Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9891981331 |
| Fax |
|
| Email |
dramit2411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ammapalem Satish |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh. |
| Address |
Department of General Surgery, Level 6, Medical college building, All India Institute of Medical Sciences, Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9000932213 |
| Fax |
|
| Email |
satishsvmc2k8@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
All India Institute of Medical Sciences, Rishikesh. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ammapalem Satish |
All India Institute of Medical Sciences, Rishikesh. |
C block,Level 5,division 531, IPD,Department of General Surgery, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL |
9000932213
satishsvmc2k8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Rishikesh, Institutional Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epigastric port retrieval |
Gall bladder retrieval through Epigastric port in elective laparoscopic cholecystectomy for gall stone disease with assessment of intraoperative parameters and patient follow up for postoperative complications till 1 month |
| Comparator Agent |
Umbilical port retrieval |
Gall bladder retrieval through Umbilical port in elective laparoscopic cholecystectomy for gall stone disease with assessment of intraoperative parameters and patient follow up for postoperative complications till 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age between 18 years to 65 years
2) All patients consenting for the study
3) All patients undergoing elective laparoscopic cholecystectomy for gall stone disease |
|
| ExclusionCriteria |
| Details |
1) Patients with bmi more than 40
2) Patients with suspected malignancy
3) Intraoperative bile or stone spillage during dissection
2) Conversion to open procedure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative pain assessment using VAS score
|
6 hours, 12 hours and 24 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate total requirememt of postoperative analgesics
To estimate time taken for gall bladder retrieval
To determine proportion of retrieval associated bile or stone spillage
To assess postoperative port site infection on day 7 day 15 and day 30 |
Postoperative
Intraoperative
Intraoperative
Postoperative day 7 day 15 and day 30 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic cholecystectomy is gold standard technique for gall bladder diseases. Gallbladder can be extracted either from the epigastric port or umbilical port. Regarding choice of exit port and use of endobag for retrieval, the SAGES guidelines for biliary surgery state “With no data to guide choice of technique, the gallbladder may be extracted as the surgeon prefers (2010) (Level III, Grade C)â€. Multiple studies including RCT’s and Meta analysis have been performed comparing both the ports for gallbladder retrieval in multiport LC, however none of the studies has given a clear message regarding the optimal port site for retrieval. The purpose of this study is to define the optimal port for gallbladder retrieval by comparing the two ports with respect to parameters like postoperative pain, total requirement of postoperative analgesia, gallbladder retrieval time and port site infection (SSI).
|